The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Direct Bilirubin.
| Device ID | K022180 |
| 510k Number | K022180 |
| Device Name: | DIRECT BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Michele Smith-waheed |
| Correspondent | Michele Smith-waheed ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2002-09-06 |
| Summary: | summary |